CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CROSSROAD: A Prospective Multicenter Observational Study on the Efficacy of Treatment Regimen Switch With Re-induction Chemotherapy Versus Direct Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Inadequate Response (SD/PD) After Induction Chemotherapy
Overview
This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.
Primary outcome measures
- Progression-Free Survival [Time frame: Baseline, 1 year, 2 years, 3 years]
Secondary outcome measures (5)
- Local Regional Recurrence-Free Survival [Time frame: Baseline, 1 year, 2 years, 3 years]
- Overall Survival [Time frame: Baseline, 1 year, 2 years, 3 years]
- Distant Metastasis-Free Survival [Time frame: Baseline, 1 year, 2 years, 3 years]
- Complete Response Rate after Radiotherapy [Time frame: 3 months post-treatment]
- 3-4 Grade Acute Toxicity Incidence [Time frame: through study completion, an average of 4-6 months]
Eligibility criteria
Inclusion criteria
Age: 18 to 70 years old.
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III).
Initial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC/UICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0).
Completion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.).
Post-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx.
ECOG Performance Status (PS): 0-1.
Bone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced).
Informed consent: Voluntary participation in the study and signing of written informed consent.
Exclusion criteria
History of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer).
Partial response (PR) or complete response (CR) after induction chemotherapy.
Severe uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus.
Active infection or severe immunodeficiency diseases.
Pregnant or breastfeeding women.
Any mental or social disorders that may interfere with study evaluation or compliance.
Other conditions deemed by the investigator to be unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07399158 · 2026-01-17